Steps of Certification
Step 1: Request Application
The first step in the process is to obtain an Application Package from
the AOAC RI. This package contains information about the program, what
types of data are required, application fees, and the agreements.
Step 2: Submit Performance Data
Manufacturers are required to collect and submit data to the AOAC RI
that supports the product performance claims of the test kit. This data
should follow the guideline of the Data Submission Requirement documents
and be submitted in a method validation report format. In addition, the
manufacturer must submit QA/QC information, package insert/user manuals,
fee, and application.
Step 3: Review of Submitted Data
Usually two Expert Reviewers are recruited and one General Referee
selected by the AOAC RI to review the performance data collected and submitted
by the test kit manufacturer. The Expert Reviewers and the General Referee
first evaluate the product descriptive inserts to determine the completeness
of the inserts and to determine the exact performance claims made for the
test kit. Then the Expert Reviewers and the General Referee evaluate the
submitted the performance data to determine whether or not the data supports
the product.
Step 4: Development of Independent Testing Lab
Protocols
After the Expert Reviewers and General Referee have determined the
adequacy of the product descriptive inserts and confirmed that the submitted
data supports the product performance claims, then the Expert Reviewers
and General Referee develop a testing protocol for the Independent Testing
Laboratory selected by the AOAC RI to conduct additional performance testing
of the test kit.
Step 5: Independent Testing
Test kits, samples and the testing protocol developed by the Expert
Reviewers and the General Referee are forwarded to the Independent Testing
Laboratory which then conducts additional performance testing of the test
kit.
Step 6: Review of Independent Testing Lab Data
The data generated by the Independent Testing Lab is sent to the AOAC
RI, and then distributed back to the Expert Reviewers and the General Referee.
The Expert Reviewers and the General Referee then review the data generated
by the Independent Testing Lab to determine whether or not this data corroborates
with the data originally submitted by the manufacturer.
Step 7: Recommendation
If the Expert Reviewers and the General Referee determine that the
independent testing lab data corroborates with the manufacturer generated
data submitted with the application, and that the product descriptive inserts
adequately describe the product performance, then a recommendation is made
to grant Performance Tested Methods status to the test kit, and the kit
manufacturer is licensed to use the certification mark for one year.
APPROVAL
Publication
Successful test kit certifications will be announced in the AOAC magazine,
Inside
Laboratory Management, with selected portions of the performance data
of the test kit may also be published. A more complete method validation
report describing the method and the evaluation is published in the Journal
of the AOAC INTERNATIONAL.
Annual Renewal
Performance Tested Methods status must be renewed on an annual
basis. AOAC RI reviews the kit package insert/user manual to ensure the
kit still conforms to the conditions of the Performance Tested Methods
certification. The manufacturer must sign the renewal application certifying
that no changes have been made to the test kit, the package insert, the
manufacturing and quality assurance programs since originally receiving
Performance
Tested Methods status. This annual review ensures that no changes have
occurred in the test kit that may adversely affect the performance of the
test kit and ensures that the package inserts and user manual remain accurate.
Changes in the Test Kit
It is the test kit manufacturer's contractual obligation to immediately
notify the AOAC RI if and when any changes are made to: (1) the instructions
for using the kit or (2) the kit's performance. Failure to promptly
notify the AOAC RI of kit changes may result in cancellation of the Performance
Tested Methods certificate. If changes are made in the test kit,
the submission of new performance data similar to the original data package
must be provided. When the AOAC RI receives notice of a kit change, the
managing director, generally in consultation with appropriate experts,
will determine if the changes are of sufficient magnitude to warrant a
complete reevaluation of the kit. If so, the applicant of record must submit
a complete application with the corresponding fee.
Complaints
The manufacturer must maintain a record of complaints and their resolution,
which will be made available to the AOAC RI on request. Failure to adequately
address user complaints will result in the AOAC RI initiating an inquiry
and could lead to cancellation of the kit's Performance Tested Methods
status. |
